Primary contact

ORCID ID

Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0515163806

Study information

Scientific title

Acronym

Study hypothesis

To evaluate a new device (patent publication GB2366729) for identification of the epidural space. In particular to test the claimed advantages:1. Reducing failure rates for epidural insertions which are presently quoted in the literature at a range of 7-23% or an average of 15%2. Reducing the number of attempts before achieving a successful epidural insertion3. Reducing the insertion time4. Ease of use scale5. Steep or zero learning curve

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Anaesthesia

Intervention

Randomised Controlled Trial

Intervention type

Device

Phase

Not Specified

Drug names

Primary outcome measures

Detailed in protocol and its supplements. Will be misleading to attempt to cover that in this small space.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/12/2002

Overall trial end date

30/10/2007

Reason abandoned

Eligibility

Participant inclusion criteria

We have estimated that 400 patients (200 Epidrums) will be required for this study. This was estimated for the required significance of difference at a p value of less than 0.05 and for the average failure rate quoted above, number of attempts at epidural needle insertion and ease of its use scale, and the expected differences in learning curves. We estimated that the power of this study with the number of patients above will not be enough for incidence of complication such PDPH, and neurological complications which will be tested later in larger multi-centre trials. Two hundred patients in each group, sixteen to eighty years.

Inclusion criteria: 1. Patients over 18 and under 80 years of age2 Clinical need for epidural injection3. Absence of any contraindication to epidural injection, relative or absolute

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

400

Participant exclusion criteria

1. Patients under 18 and over 80 years of age2. Bleeding tendency, local infection, bacteraemia or septicaemia3. Unable or unwilling to give consent4. All other relative clinical contraindications to epidural injection or anaesthesia

Recruitment start date

01/12/2002

Recruitment end date

30/10/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Anaethetics Level 4J
Harrow
HA1 3UJ
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health